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For our offices in Vienna, Austria, we are looking for a

Regulatory Affairs Consultant (m/f/d)

Fulltime (40 hours)

Main responsibilities:

  • Dealing with and responding to routine regulatory queries for information and documents in a timely, priority driven manner.
  • Prepare, compile, review and/or submit regulatory documentation to regulatory authorities and Notified bodies.
  • Write Module 3 documents - CMC
  • Handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralized Applications, medical device CE marking and food supplement notifications.
  • Complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries.
  • Dossier and development gap analysis (drugs, food supplements) maintain current technical files and declarations of conformity in accordance with the Medical Device Directives.
  • Respond to customer queries and questionnaires for regulatory information.

Experience, skills and education:

  • Master’s degree (PhD preferred) in a relevant subject: Biotechnology, chemistry, biology or a similar background.
  • 3-5 years experience in a similar position.
  • Computer proficiency and adaptability working with a variety of databases, word processing, spreadsheet, etc.
  • Experience with vaccines and biotech products.
  • Ability to create effective reports and analysis and communicate them in a timely and effective manner.
  • Ability to work in a team environment with shifting priorities and requirements.
  • Experience with writing module 3 documents, CMC
  • Ability and willingness to learn legal aspects of drug, medical device and food registrations.
  • Proficient in English and German.
  • Willingness to work at client sites in Europe.

Your salary will be based on experience but will meet the legal requirements according to the Austrian laws and regulations.

Application:

To apply for this position please send your letter of motivation and your CV to office@michor-consulting.eu.
For further questions please do not hesitate to send us an e-mail or call us: + 43 (0)699 195 216 62
We are looking forward to meeting you!
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